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Trial · Interventional

TerminatedNot applicableResults postedRegistry data

Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer

NCTNCT00070317 (opens ClinicalTrials.gov in a new tab)Other idGOG-0206Other idNCI-2012-02559Other idCDR0000331918Other idGOG-0206
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Not applicable
Enrollment
102 participants (actual)
Sponsor
Gynecologic Oncology Group · Network
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Jun 2004
Primary completion
Jan 2013
Completion
Jan 2013
First posted
7 Oct 2003 (estimated)
Last update posted
6 Nov 2017
Conditions
Cervical Adenocarcinoma · Cervical Adenosquamous Carcinoma · Cervical Squamous Cell Carcinoma · Stage I Cervical Cancer

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200420062008201020122014
  1. N/A

    Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer

    NCT00070317

    Jun 2004 to Jan 2013

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This clinical trial is studying how well lymph node mapping and sentinel lymph node identification work in finding lymph node metastases in patients with stage IB1 cervical cancer. Diagnostic procedures, such as lymph node mapping and sentinel lymph node identification, performed before and during surgery, may improve the ability to detect lymph node metastases in patients who have cervical cancer.

Interventions

  • Isosulfan BlueDrug
  • Lymph Node MappingProcedure
  • LymphangiographyProcedure
  • Methylene BlueDrug
  • Radionuclide ImagingProcedure
  • Sentinel Lymph Node BiopsyProcedure
  • Technetium Tc-99m Sulfur ColloidRadiation
  • Therapeutic Conventional SurgeryProcedure

Arms1

  • Experimental

    Diagnostic

    Patients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor 6 hours prior to or after induction of anesthesia right before surgery. Patients then undergo radical hysterectomy and complete pelvic and low para-aortic lymphadenectomy. Intraoperatively, patients undergo lymphatic mapping and sentinel lymph node identification using isosulfan blue or methylene blue injected at 4 locations in the cervix and a hand-held gamma counter.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Sensitivity

    Time frame · At the time of surgery

    Registry description

    Sensitivity is defined as the proportion of patients who test as positive sentinel node among the patients who have lymph node metastases.

  2. False Negative Predictive Value (FNPV)

    Time frame · At the time of Surgery

    Registry description

    The proportion of patients with FNPV among patients who tests as negative sentinel node, where FNPV is defined as a person who tests as negative sentinel node but who actually has lymph node metastases

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· At the time of surgery

Sensitivity

GroupValue (Percentage of participants)
Diagnostic85.7
Primary outcomeNumber· At the time of Surgery

False Negative Predictive Value (FNPV)

GroupValue (Percentage of participants)
Diagnostic5.9

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
DiagnosticPatients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor 6 hours prior to or after induction of anesthesia right before surgery. Patients then undergo radical hysterectomy and complete pelvic and low para-aortic lymphadenectomy. Intraoperatively, patients undergo lymphatic mapping and sentinel lymph node identification using isosulfan blue or methylene blue injected at 4 locations in the cervix and a hand-held gamma counter. Isosulfan Blue: Undergo lymphangiography using isosulfan blue or methylene blue Lymph Node Mapping: Undergo lymphatic mapping Lymphangiography: Undergo lymphangiography using isosulfan blue or methylene blue Methylene Blue: Undergo lymphangiography using isosulfan blue or methylene blue Radionuclide Imaging: Undergo radionuclide imaging with technetium Tc 99m sulfur colloid Sentinel Lymph Node Biopsy: Undergo complete pelvic and low para-aortic lymphadenectomy Technetium Tc-99m Sulfur Colloid: Undergo radionuclid0 / 890 / 8932 / 89

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
Not stated
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Diagnosis of carcinoma of the cervix of 1 of the following cellular types: * Squamous cell carcinoma * Adenocarcinoma * Adenosquamous cell carcinoma * Stage IB1 disease (no greater than 4 cm) * No unequivocal evidence of metastases * Adequate surgical candidate * No known allergy to triphenylmethane compounds * No prior pelvic irradiation * No prior retroperitoneal surgery * More than 4 weeks since prior cold knife or loop electrosurgical excision procedure (LEEP) cone biopsy * Prior cone biopsy allowed provided current disease is stage IB1

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